BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Optragate Dry Control

    DI: 07615208536744 · Model: 768788 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    60

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Optragate Dry Control
    Primary DI
    07615208536744
    Version / Model
    768788
    Catalog Number
    768788
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    60
    Record Status
    Published
    Publish Date
    2025-12-04
    Public Version
    1
    Public Version Date
    2025-12-12
    Public Version Status
    New
    Public Device Record Key
    96ee87ac-c342-4478-88d8-21b733fcc569

    Device Description

    OptraGate Dry Control Refill / 60

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DYN Mouthpiece, saliva ejector

    GMDN Terms

    Code Name
    37434 Dental suction system cannula, single-use

    Identifiers

    Type ID
    Unit of Use 07615208584998
    Primary 07615208536744